Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary

AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.

Netflix Bleeding Edge documentary screen shot of Scott Whitaker
AdvaMed CEO Scott Whitaker was featured in a new Netflix documentary on how medical devices come to the US market

A new Netflix documentary by Oscar-nominated director Kirby Dick is highly critical of the medical device industry and US FDA. While the film is receiving acclaim and attention, the top lobbyist at AdvaMed says it's nothing but an "entertainment piece" and a "hit job" that misleads viewers about how products get to market.

The documentary, "The Bleeding Edge," looks at how devices are regulated in the US. It showcases examples such as

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By 

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By 

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

More from Policy & Regulation

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By 

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
• By 

The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.